Pioglitazone Accord

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

pioglitazone hydrochloride

MAH:

Accord Healthcare S.L.U.

ATC_code:

A10BG03

INN:

pioglitazone

therapeutic_group:

Drugs used in diabetes

therapeutic_area:

Diabetes Mellitus, Type 2

therapeutic_indication:

Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

leaflet_short:

Revision: 7

authorization_status:

Authorised

authorization_date:

2012-03-21

PIL

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PIOGLITAZONE ACCORD 15 MG TABLETS
PIOGLITAZONE ACCORD 30 MG TABLETS
PIOGLITAZONE ACCORD 45 MG TABLETS
Pioglitazone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICIN
e
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pioglitazone Accord is and what it is used for
2.
What you need to know before you take Pioglitazone Accord
3.
How to take Pioglitazone Accord
4.
Possible side effects
5.
How to store Pioglitazone Accord
6.
Contents of the pack and other information
1.
WHAT PIOGLITAZONE ACCORD IS AND WHAT IT IS USED FOR
Pioglitazone Accord contains pioglitazone. It is an anti-diabetic
medicine used to treat type 2 (non-
insulin dependent) diabetes mellitus in adults, when metformin is not
suitable or has failed to work
adequately. This is the diabetes that usually develops in adulthood.
Pioglitazone Accord helps control the level of sugar in your blood
when you have type 2 diabetes by
helping your body make better use of the insulin it produces. Your
doctor will check whether
Pioglitazone Accord is working 3 to 6 months after you start taking
it.
Pioglitazone Accord may be used on its own in patients who are unable
to take metformin, and where
treatment with diet and exercise has failed to control blood sugar or
may be added to other therapies
(such as metformin, sulfonylurea or insulin) which have failed to
provide sufficient control of blood
sugar.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE ACCORD
DO NOT TAKE PIOGLITAZONE ACCORD:
•
if you are allergic to pioglitazone

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pioglitazone Accord 15 mg tablets
Pioglitazone Accord 30 mg tablets
Pioglitazone Accord 45 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pioglitazone Accord 15 mg tablets
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
_Excipient_
_ with known effect_
_: _
Each tablet contains 37.24 mg of lactose monohydrate (see section
4.4).
Pioglitazone Accord 30 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
_Excipient with known effect: _
Each tablet contains 74.46 mg of lactose monohydrate (see section
4.4).
Pioglitazone Accord 45 mg tablets
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
_Excipient_
_ with known effect_
_: _
Each tablet contains 111.70 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Pioglitazone Accord 15 mg tablets
The tablets are white to off white, round, biconvex, uncoated tablets
debossed with ‘P’ on one side and
‘15’ on other side.
Pioglitazone Accord 30 mg tablets
The tablets are white to off white, flat, round uncoated tablets with
beveled edges debossed with ‘PIO’
on one side and ‘30’ on the other side.
Pioglitazone Accord 45 mg tablets
The tablets are white to off white, flat, round uncoated tablets with
beveled edges debossed with ‘PIO’
on one side and ‘45’ on the other side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pioglitazone is indicated as second or third line treatment of type 2
diabetes mellitus as described
below:
as
MONOTHERAPY
-
in adult patients (particularly overweight patients) inadequately
controlled by diet and
exercise for whom metformin is in appropriate because of
contraindications or
intolerance
as
DUAL ORAL THERAPY
in combination with
- metformin, in adult patients (particularly overweight patients) with
insufficient glycaemic control
despite maximal tolerated dose of monotherapy with metformin
- a sulphonylurea, only in